Probiotics for Girls With Recurring Urinary Tract Infections - Full Text View

Sponsor:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00789464

Purpose

Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa, thus gaining access to the bladder.

This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics + placebo) to determine if UTIs are decreased when the probiotics are given.

Condition	Intervention	Phase
Recurrent Urinary Tract Infection	Dietary Supplement: Lactobacillus reuteri DSM 17938 Drug: trimethoprim/sulfamethoxazole	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title:	H-23187: PROBIOTIC PROPHYLAXIS AGAINST RECURRENT PEDIATRIC URINARY TRACT INFECTION

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets Urinary Tract Infections

Drug Information available for: Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2009
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ARM A Probiotics drops plus placebo elixir	Dietary Supplement: Lactobacillus reuteri DSM 17938 DSM 17938 drops (10^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year.
ARM B TMP/SMZ elixir plus placebo drops	Drug: trimethoprim/sulfamethoxazole Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year.

Eligibility

Ages Eligible for Study:	3 Months to 17 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Girls age 1 through age 17 years of age
Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year preceding study inclusion or already using any form of prophylaxis to prevent recurrences of UTI
Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis.

Exclusion Criteria:

Breastfeeding
Pregnancy
Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim
Known immunosuppression i.e., transplant recipients or children with congenital immunodeficiencies
Poorly controlled diabetes
Untreated HIV infection
Use of high dose corticosteroids for autoimmune diseases or post-organ transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed.
Malnutrition
Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be excluded from the study
Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease requiring medication will be excluded from the study
Patients with known anemia will be excluded from the study
Patients taking medications that may interact with sulfamethoxazole/trimethoprim will be excluded from the study
Patients taking other probiotics will be excluded from the study
Patients already taking prophylactic antibiotics will be excluded from the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789464

Contacts

Contact: Michelle Rubio-Gonzales

832-824-3342

rubiogon@bcm.edu

Locations

United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

David R. Roth, MD

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Baylor College of Medicine ( David R. Roth, M.D. )
Study ID Numbers:	H-23187
Study First Received:	November 10, 2008
Last Updated:	July 20, 2009
ClinicalTrials.gov Identifier:	NCT00789464 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:

Urinary Tract Infection
Probiotics
Dietary Supplements
Bacteriuria

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Antiprotozoal Agents
Disease Attributes
Trimethoprim
Molecular Mechanisms of Pharmacological Action
Sulfamethoxazole
Urinary Tract Infections
Enzyme Inhibitors
Anti-Infective Agents, Urinary

Folic Acid Antagonists
Renal Agents
Infection
Recurrence
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Pathologic Processes
Urologic Diseases
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010